FDA Okays Handheld Device to Measure Airway Inflammation

NEW PROVIDENCE, N.J., March 4 -- The FDA has approved a handheld, point-of-care device to measure airway inflammation related to asthma, according to a statement from device maker, Aerocrine, Inc.

The company said the Niox Mino is the first handheld device that provides "accurate, reproducible, and immediate measurement of fractional exhaled nitric oxide (FENO), a validated method for assessing asthma-related airway inflammation."

Although the device would not replace spirometry, which measures pulmonary function, Aerocrine claimed that FENO measurement can capture inflammatory changes following allergen exposure at an earlier stage than spirometry, "making it a more sensitive marker [for asthma]."

"Niox Mino answers the need for a user-friendly, non-invasive, accurate, and cost-effective tool that enables any physician to monitor the underlying process of asthma-airway inflammation," said Peter B. Boggs, M.D., of Louisiana State University in Shreveport, in a press release issued by Aerocrine.

The device is already "used extensively" in Europe, the manufacturer said.